Senior Scientific Director, Neuroscience
Posted on: August 5, 2022
Clinical Development: Oversees the direction, planning,
execution, and interpretation of clinical trials/research and the
data collection activities of one or more clinical development
programs. - Establishes and approves scientific methods for design
and implementation of clinical protocols, data collection systems
and final reports. - May recruit clinical investigators and
negotiates study design. - Responsible for creating clinical
development plans and for directing human clinical trials, phases I
- IV for company products under development. - Expertise/experience
-in Neuroscience preferred.
- Responsibilities also include adverse event reporting and
safety responsibilities monitoring. -
- Coordinates and develops reporting information for reports
submitted to Global Regulatory Authorities, including EMEA, FDA,
and other national authorities. -
- Monitors adherence to protocols and determines study
completion. - May act as consultant/liaison with other corporations
when working under licensing agreements.
- Accountable for the design and management of clinical
development plans based on strong medical and scientific
principals, knowledge of the regulatory requirements and AbbVie's
customers, markets, business operations and emerging
- Responsibility may extend from early translational development
activities to mature product life cycle management
- Manages the design, conduct and reporting of clinical trials in
line with the development, regulatory and commercial
- May supervise 2-10 employees either directly or in a matrixed
- Should be able to serve as a global product safety offices,
responsible for global product safety.
- Participation in design and execution of clinical trial safety,
product safety and risk management plans. -
- Responsible for routine and ad-hoc safety monitoring reports to
regulatory agencies. May review, assess and report applicable
Adverse Events (AE's) and Serious Adverse Events (SAE's) if
assigned to AbbVie conduct on clinical studies. Oversees the
conduct of clinical trials and is medically and scientifically
accountable for resolution of safety (AE's & SAE's) issues,
interpretation of statistical analyses for clinical significance,
PI selection, scientific documents reporting safety monitoring and
other scientific reports submitted to the regulatory
- May be responsible for opinion leader development within one or
more therapeutic area(s).
- May act as consultant/liaison with other corporations when
working under licensing agreements and/or in the evaluation of new
business development opportunities.
- Oversee scientific/medical education of investigators, clinical
monitors, and Global Project Team members related to therapeutic
area or disease specific information.
- Keeps abreast of professional information and technology
through conferences and/or medical literature and acts as a
therapeutic area resource.
- Represents AbbVie at external meetings including investigator
meetings, scientific association meetings, etc.
- Responsible for understanding the regulatory requirements
related to the clinical studies and global drug development and
accountable for complying with those requirements. Serves as the
scientific team interface for key regulatory discussions
- Act as the scientific leader for several clinical programs
within an area.
- May represent the medical function to the GPT for clinical
- With project director, responsible for setting clinical trial
strategy to carry out overall program objectives
- With project director, ensures budgets, timelines, compliance
requirements are factored into programs' scientific
- Works independently.
- Can address complex problems within discipline or across
- Exercises judgment within broadly defined practices and
policies in selecting methods and techniques for obtaining
- Works on complex problems in which analysis of situation or
data requires an in-depth evaluation of various complex factors
PhD -with relevant therapeutic specialty in an academic or hospital
Completion of fellowship is preferred.
Minimum of 5 years of clinical trial experience in the
pharmaceutical industry or academia or equivalent. - 7+ years of
experience is preferred.
Proven leadership skills in a cross-functional global team
Ability to interact externally and internally to support global
business strategy. -
Ability to run a complex clinical program independently.
Extensive knowledge of clinical trial methodology, regulatory
requirements governing clinical trials and experience in
development strategy and the design of protocols. -
This knowledge set is typically associated with a minimum of 7
years of clinical development experience in a pharmaceutical
company/CRO/Bio Technology company plus expert knowledge in a
relevant therapeutic specialty. -
Must have an understanding of Pharmacovigilance practices for
Clinical Development programs. - - Ability to interact externally
and internally to support global business strategies. -
Must possess excellent oral and written English communication
skills. Must have an in-depth understanding of the Clinical
Development process for Phase I-IV or extensive knowledge of
Pharmaceutical Development including compliance and regulatory
Keywords: AbbVie, Irvine , Senior Scientific Director, Neuroscience, Executive , Irvine, California
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